Article 46
Union safeguard procedure
In short: Appeal process related to measures taken by a member state market surveillance authority
- Where, under Article 44(2) and Article 45(3),
objections are raised against a national measure taken by a market surveillance
authority, or where the Commission considers a national measure to be contrary to Union law, the Commission shall without delay
enter into consultations with that market surveillance authority and the relevant economic operators and shall evaluate the
national measure concerned. On the basis of the results of that evaluation, the Commission shall adopt an implementing decision
determining whether the national measure is justified. That implementing decision shall be adopted in accordance with the
examination procedure referred to in Article 98(2). The Commission shall address its implementing decision to all
Member States and shall immediately communicate it to them and to the relevant economic operators.
- If the national measure referred to in paragraph 1 is considered justified by the Commission, all Member States
concerned shall take the necessary measures to ensure that the non-compliant EHR system is withdrawn from their market,
and shall inform the Commission accordingly.
If the national measure referred to in paragraph 1 is considered unjustified by the Commission, the Member State
concerned shall revoke that measure.
Discussion
Feedback
Please e-mail
ehds@ringholm.com should the information on this page be incorrect or incomplete; we welcome your suggestions to improve its content.
About Ringholm bv
Ringholm bv is a group of European experts in the field of messaging standards and systems integration in healthcare IT.
We provide the industry's most advanced training courses and consulting on healthcare information exchange standards.
